10-Q – Quarterly report [Sections 13 or 15(d)]

MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Oncotelic Appoints Fatih Uckun, M.D., Ph.D., as Chief Medical Officer

On May 3, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company" or "We") (OTCQB:OTLC), reported the appointment of Dr. Fatih Uckun as its Chief Medical Officer. Dr. Uckun will be responsible for execution of internal company led registrational trials (Press release, Mateon Therapeutics, MAY 3, 2022, View Source [SID1234613789]).

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"The addition of Dr. Uckun to our executive team, comes at a critical time for Oncotelic. We have made significant inroads toward our goal of developing OT-101 as treatment for difficult to treat cancers," said Dr. Vuong Trieu, CEO and Chairman. "Dr. Uckun is one of the highest caliber physician scientists. His deep knowledge in clinical oncology and vast experience in translational research for successful applications of immunotherapy in oncology, especially for difficult to treat cancer subtypes will be invaluable, as we further advance OT-101 and the rest of our product portfolio."

"With the completion of the joint venture with Dragon Overseas Capital Limited for OT-101, we will be initiating OT-101 registration trials against difficult to treat cancers such as DIPG and pancreatic cancers", said Dr. Fatih Uckun, CMO. "I look forward to engaging the global oncology community in bringing OT-101 to these patients."

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar.

Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals (from 2020 to 2022), Chief Medical Officer of Ares Pharmaceuticals (from 2017 to 2022), Chief Clinical Advisor of Aptevo Therapeutics (2021), Vice President and Clinical Strategy Lead, Oncology-Hematology of Worldwide Clinical Trials (2020), Chief Medical Officer of Mateon and Oncotelic (2019-2020), and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health (from 2017 to 2018). Prior to this, he was Vice President of Research and Clinical Development at Nantkwest, Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters and and is an inventor on numerous patents.

Dr. Uckun worked as a Professor of Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer.

Distributors Agree to Opioid Settlement With Washington State

On May 3, 2022 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Washington Attorney General, under which the distributors will pay up to $518 million to the State of Washington and its participating subdivisions to resolve opioid-related claims (Press release, Cardinal Health, MAY 3, 2022, View Source [SID1234613639]). This amount is consistent with Washington’s allocation under the previously announced comprehensive agreement to settle the vast majority of the opioid lawsuits filed by state and local governmental entities, as well as certain attorneys’ fees and costs.

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Upon effectiveness of the settlement, the State of Washington will dismiss the lawsuit that is currently being tried. The agreement is subject to certain contingencies, including the rate of subdivision participation. The terms of the agreement with the State of Washington are consistent with the comprehensive settlement agreement, which became effective on April 2, 2022.

While the companies strongly dispute the allegations made in the plaintiffs’ complaints and during trial, they believe that resolving all of the litigation filed by the State of Washington and its political subdivisions will further the companies’ goal of achieving broad resolution of governmental opioid claims while delivering meaningful relief to communities across the United States that have been impacted by the opioid epidemic.

Evotec SE to announce results for the first quarter 2022 on 11 May 2022

On May 3, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that it will announce its financial results for the first quarter of 2022 on Wednesday, 11 May 2022 (Press release, Evotec, MAY 3, 2022, View Source [SID1234613504]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

Notification Regarding Revision of Consolidated Financial Forecasts (IFRS) for the Fiscal Year Ended March 31, 2022

On May 3, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that based on the impact of National Coverage Determination (NCD) for the anti-amyloid-beta antibody aducanumab (product name in the U.S.: ADUHELM) issued by the U.S. Centers for Medicare & Medicaid Services’ (CMS) on April 7, 2022 and other factors, Eisai has revised its consolidated financial forecasts for the fiscal year ended March 31, 2022 (April 1, 2021 to March 31, 2022) previously announced on November 1, 2021, as follows (Press release, Eisai, MAY 3, 2022, View Source [SID1234613501]).

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1. Revised consolidated financial forecasts for the fiscal year ended March 31, 2022 (April 1, 2021 to March 31, 2022)

2. Reason for revision of the consolidated financial forecasts
Revenue is estimated to be ¥756.0 billion, up ¥26.0 billion from the previously announced forecasts, based on product performance and foreign exchange trends.
Receiving Biogen Inc.’s updated demand forecast for aducanumab based on the NCD by CMS, Eisai will record an impairment loss of ¥8.0 billion in cost of sales after reevaluating sales rights of aducanumab recorded by Eisai as well as ¥16.5 billion in SG&A expenses as Eisai’s share of the write-down of inventory recorded by Biogen Inc. As a result, operating profit is estimated to be ¥53.5 billion, down ¥24.5 billion from the previously announced forecast. Accordingly, profit attributable to owners of the parent is expected to be ¥48.0 billion, down ¥12.5 billion from the previously announced forecast. There are no changes to the total dividend for the fiscal year which is set at ¥160 per share (same amount as the previous fiscal year) with the fiscal year-end dividend is planned to be ¥80 per share.

*Please note that the above-mentioned forecasts were made based on information available as of May 3, 2022. Actual results will be disclosed in the earnings announcement on May 13, 2022